A phase III clinical trial of adjuvant treatment with Sacituzumab and Zimberelimab for stage IB-IIIA-IIIB (N2) previously resected (R0) non-small cell lung cancer (NSCLC) patients that did not achieve pathological complete response after neoadjuvant treatment (ARIAN)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512960-75-00

Acronym

GECP 23/03

Enrollment

129

Registered

2024-08-19

Start date

2025-02-04

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Non-small cell lung cancer

Brief summary

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Detailed description

1. Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment, 2. Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0

Interventions

DRUGZimberelimab

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.	—

Secondary

Measure	Time frame
1. Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment, 2. Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026